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FDA expands approval of 9-valent HPV vaccine
The , men and women aged 27-45 years, the Food and Drug Administration announced on Oct. 5.
The vaccine (Gardasil 9) was previously approved for those aged 9-26 years.
The approval “represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA statement announcing the approval.
“The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing,” he added.
Gardasil 9, approved in 2014, covers the four HPV types included in the original Gardasil vaccine approved in 2006, plus five additional HPV types.
The approval is based on the results of a study and follow-up of about 3,200 women aged 27-45 years, followed for an average of 3.5 years, which found that the vaccine was 88% percent effective “in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine,” according to the FDA. The vaccine’s effectiveness in men in this age group is “inferred” from these results and from data on Gardasil in men aged 16-26 years, as well as “immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months,” the FDA statement noted.
Based on safety data in about 13,000 men and women, injection-site pain, swelling, redness, and headaches are the most common adverse reactions associated with Gardasil 9, the statement said. Gardasil 9 is manufactured by Merck.
The , men and women aged 27-45 years, the Food and Drug Administration announced on Oct. 5.
The vaccine (Gardasil 9) was previously approved for those aged 9-26 years.
The approval “represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA statement announcing the approval.
“The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing,” he added.
Gardasil 9, approved in 2014, covers the four HPV types included in the original Gardasil vaccine approved in 2006, plus five additional HPV types.
The approval is based on the results of a study and follow-up of about 3,200 women aged 27-45 years, followed for an average of 3.5 years, which found that the vaccine was 88% percent effective “in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine,” according to the FDA. The vaccine’s effectiveness in men in this age group is “inferred” from these results and from data on Gardasil in men aged 16-26 years, as well as “immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months,” the FDA statement noted.
Based on safety data in about 13,000 men and women, injection-site pain, swelling, redness, and headaches are the most common adverse reactions associated with Gardasil 9, the statement said. Gardasil 9 is manufactured by Merck.
The , men and women aged 27-45 years, the Food and Drug Administration announced on Oct. 5.
The vaccine (Gardasil 9) was previously approved for those aged 9-26 years.
The approval “represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA statement announcing the approval.
“The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing,” he added.
Gardasil 9, approved in 2014, covers the four HPV types included in the original Gardasil vaccine approved in 2006, plus five additional HPV types.
The approval is based on the results of a study and follow-up of about 3,200 women aged 27-45 years, followed for an average of 3.5 years, which found that the vaccine was 88% percent effective “in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine,” according to the FDA. The vaccine’s effectiveness in men in this age group is “inferred” from these results and from data on Gardasil in men aged 16-26 years, as well as “immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months,” the FDA statement noted.
Based on safety data in about 13,000 men and women, injection-site pain, swelling, redness, and headaches are the most common adverse reactions associated with Gardasil 9, the statement said. Gardasil 9 is manufactured by Merck.
Experimental drugs deployed in Ebola response
SAN FRANCISCO – For the first time, the World Health Organization’s Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) protocol is being field tested in the Democratic Republic of Congo (DRC), where four different therapeutics are being delivered to Ebola patients. MEURI was created after controversy surrounding the 2014-2016 Ebola outbreak in West Africa, which ultimately led to the decision to integrate research into outbreak responses.
MEURI is broadly designed for pathogens that have no proven intervention, on the premise that in a disease with high mortality, it can be ethically appropriate to provide experimental therapies during a response, as long as a set of criteria are met that ensure patient autonomy and give patients a reasonable opportunity to improve their condition.
The original plan was to employ experimental drugs under the MEURI umbrella during an Ebola outbreak in the DRC that began in May, but an effective response contained it so quickly that the program was canceled. However, when another Ebola outbreak occurred on Aug. 27, the material was still in the country and ready to be deployed. “That made it very easy to begin using them,” said Elizabeth Higgs, MD, global health science advisor for the division of clinical research at the National Institute for Allergy and Infectious Disease.
Dr. Higgs spoke about the developments during a late-breakers session at IDWeek 2018, an annual scientific meeting on infectious disease.
The therapies under consideration are Zmapp (Leaf Biopharmaceutical), which includes three chimeric monoclonal antibodies that target the main surface protein of the Ebola virus; mAb114 (NIAID), which was isolated in 1995 from a human survivor of Ebola and binds to the core of the Ebola surface protein; Remdesivir (Gilead), a small molecule that is believed to interfere with viral replication; and Regeneron’s Ebola triple monoclonal antibody cocktail, which also targets the surface protein.
Through Oct. 2, 43 Ebola patients have received one of the four drugs: 19 are cured and have been discharged, 12 have died, and 12 are still in recovery. Dr. Higgs cautioned against reading anything into those numbers, however, since no randomization was involved.
Although compassionate use is the primary aim of MEURI, it may be lead to some scientific benefit. The most that can be hoped for is to glean some insight into the safety of the interventions, although even that information is limited. “A colleague and I were talking about this the other day. After the first X number of patients, they were all still alive. What can you say from that? I think what you can say is that it didn’t kill them,” Dr. Higgs said.
Still, researchers are collecting laboratory data from patients to monitor their responses. “With Remdesivir we’re closely examining their transaminase, for example, so I think it will be helpful,” said Dr. Higgs.
SOURCE: Higgs E et al. IDWeek 2018.
SAN FRANCISCO – For the first time, the World Health Organization’s Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) protocol is being field tested in the Democratic Republic of Congo (DRC), where four different therapeutics are being delivered to Ebola patients. MEURI was created after controversy surrounding the 2014-2016 Ebola outbreak in West Africa, which ultimately led to the decision to integrate research into outbreak responses.
MEURI is broadly designed for pathogens that have no proven intervention, on the premise that in a disease with high mortality, it can be ethically appropriate to provide experimental therapies during a response, as long as a set of criteria are met that ensure patient autonomy and give patients a reasonable opportunity to improve their condition.
The original plan was to employ experimental drugs under the MEURI umbrella during an Ebola outbreak in the DRC that began in May, but an effective response contained it so quickly that the program was canceled. However, when another Ebola outbreak occurred on Aug. 27, the material was still in the country and ready to be deployed. “That made it very easy to begin using them,” said Elizabeth Higgs, MD, global health science advisor for the division of clinical research at the National Institute for Allergy and Infectious Disease.
Dr. Higgs spoke about the developments during a late-breakers session at IDWeek 2018, an annual scientific meeting on infectious disease.
The therapies under consideration are Zmapp (Leaf Biopharmaceutical), which includes three chimeric monoclonal antibodies that target the main surface protein of the Ebola virus; mAb114 (NIAID), which was isolated in 1995 from a human survivor of Ebola and binds to the core of the Ebola surface protein; Remdesivir (Gilead), a small molecule that is believed to interfere with viral replication; and Regeneron’s Ebola triple monoclonal antibody cocktail, which also targets the surface protein.
Through Oct. 2, 43 Ebola patients have received one of the four drugs: 19 are cured and have been discharged, 12 have died, and 12 are still in recovery. Dr. Higgs cautioned against reading anything into those numbers, however, since no randomization was involved.
Although compassionate use is the primary aim of MEURI, it may be lead to some scientific benefit. The most that can be hoped for is to glean some insight into the safety of the interventions, although even that information is limited. “A colleague and I were talking about this the other day. After the first X number of patients, they were all still alive. What can you say from that? I think what you can say is that it didn’t kill them,” Dr. Higgs said.
Still, researchers are collecting laboratory data from patients to monitor their responses. “With Remdesivir we’re closely examining their transaminase, for example, so I think it will be helpful,” said Dr. Higgs.
SOURCE: Higgs E et al. IDWeek 2018.
SAN FRANCISCO – For the first time, the World Health Organization’s Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) protocol is being field tested in the Democratic Republic of Congo (DRC), where four different therapeutics are being delivered to Ebola patients. MEURI was created after controversy surrounding the 2014-2016 Ebola outbreak in West Africa, which ultimately led to the decision to integrate research into outbreak responses.
MEURI is broadly designed for pathogens that have no proven intervention, on the premise that in a disease with high mortality, it can be ethically appropriate to provide experimental therapies during a response, as long as a set of criteria are met that ensure patient autonomy and give patients a reasonable opportunity to improve their condition.
The original plan was to employ experimental drugs under the MEURI umbrella during an Ebola outbreak in the DRC that began in May, but an effective response contained it so quickly that the program was canceled. However, when another Ebola outbreak occurred on Aug. 27, the material was still in the country and ready to be deployed. “That made it very easy to begin using them,” said Elizabeth Higgs, MD, global health science advisor for the division of clinical research at the National Institute for Allergy and Infectious Disease.
Dr. Higgs spoke about the developments during a late-breakers session at IDWeek 2018, an annual scientific meeting on infectious disease.
The therapies under consideration are Zmapp (Leaf Biopharmaceutical), which includes three chimeric monoclonal antibodies that target the main surface protein of the Ebola virus; mAb114 (NIAID), which was isolated in 1995 from a human survivor of Ebola and binds to the core of the Ebola surface protein; Remdesivir (Gilead), a small molecule that is believed to interfere with viral replication; and Regeneron’s Ebola triple monoclonal antibody cocktail, which also targets the surface protein.
Through Oct. 2, 43 Ebola patients have received one of the four drugs: 19 are cured and have been discharged, 12 have died, and 12 are still in recovery. Dr. Higgs cautioned against reading anything into those numbers, however, since no randomization was involved.
Although compassionate use is the primary aim of MEURI, it may be lead to some scientific benefit. The most that can be hoped for is to glean some insight into the safety of the interventions, although even that information is limited. “A colleague and I were talking about this the other day. After the first X number of patients, they were all still alive. What can you say from that? I think what you can say is that it didn’t kill them,” Dr. Higgs said.
Still, researchers are collecting laboratory data from patients to monitor their responses. “With Remdesivir we’re closely examining their transaminase, for example, so I think it will be helpful,” said Dr. Higgs.
SOURCE: Higgs E et al. IDWeek 2018.
REPORTING FROM ID WEEK 2018
Key clinical point:
Major finding: Since Oct. 2, 43 Ebola patients have received one of the four drugs: 19 were cured; 12 died, and 12 are in recovery.
Study details: Therapies are Zmapp (Leaf Biopharmaceutical), mAb114 (NIAID), Remdesivir (Gilead), and Regeneron’s Ebola triple monoclonal antibody cocktail.
Disclosures: Dr. Higgs reported no conflicts of interest.
Source: Higgs E et al. ID Week 2018.
Half of outpatient antibiotics prescribed with no infectious disease code
based on a review of more than half a million outpatient prescriptions to more than a quarter million patients at 514 clinics around Chicago.
The researchers looked to see if prescriptions had an ICD-10 code that indicated an antibiotic; they were liberal in their approach, considering over 21,000 codes to at least possibly signal the need for an antibiotic.
Almost half the time, there was nothing in the codes related to bacterial infection: 29% of scripts were written in connection with codes for high blood pressure, annual visits, and other noninfectious disorders; 17% of prescriptions were written with no diagnosis code at all.
The study is likely the largest to date to look at outpatient antibiotic prescribing patterns in the United States, and the findings are worrisome. “Nearly half the time, clinicians have either a bad reason for prescribing antibiotics, or don’t provide a reason at all. When you consider about 80% of antibiotics are prescribed on an outpatient basis, that’s a concern,” lead investigator Jeffrey A. Linder, MD, MPH, chief of the division of general internal medicine and geriatrics at Northwestern University, Chicago, said in a written statement.
“At busy clinics, sadly, the most efficient thing to do is just call in an antibiotic prescription. We need to dig into the data more, but we believe there is a lot of antibiotic prescribing for colds, the flu, and non-specific symptoms such as just not feeling well,” he said.
With all the concern in recent years about overuse, it’s hard to imagine that prescribers are still being free and easy with antibiotics, and Dr. Linder’s study will certainly have its skeptics.
Sloppy record keeping could be one explanation for the findings. A patient could really have needed an antibiotic, but it just wasn’t captured in coding. There are also valid reasons for prescribing antibiotics over the phone, such as acne and recurrent UTIs.
Dr. Linder, however, thinks it’s more than that. He explained his study, its implications, and the next steps in an interview at ID Week, an annual scientific meeting on infectious diseases.
The 2,413 prescribers in the study included physicians, surgeons, residents, fellows, nurse practitioners, and physician assistants in general and specialty practices. Patients were a mean of 43 years old: 60% were women and 75% were white. The most common antibiotic classes were penicillins, macrolides, and cephalosporins. Prescriptions were written from November 2015 through October 2017.
The work was funded by the Agency for Healthcare Research and Quality. Dr. Linder did not have any disclosures.
SOURCE: Linder JA et al. ID Week 2018 abstract 1632.
based on a review of more than half a million outpatient prescriptions to more than a quarter million patients at 514 clinics around Chicago.
The researchers looked to see if prescriptions had an ICD-10 code that indicated an antibiotic; they were liberal in their approach, considering over 21,000 codes to at least possibly signal the need for an antibiotic.
Almost half the time, there was nothing in the codes related to bacterial infection: 29% of scripts were written in connection with codes for high blood pressure, annual visits, and other noninfectious disorders; 17% of prescriptions were written with no diagnosis code at all.
The study is likely the largest to date to look at outpatient antibiotic prescribing patterns in the United States, and the findings are worrisome. “Nearly half the time, clinicians have either a bad reason for prescribing antibiotics, or don’t provide a reason at all. When you consider about 80% of antibiotics are prescribed on an outpatient basis, that’s a concern,” lead investigator Jeffrey A. Linder, MD, MPH, chief of the division of general internal medicine and geriatrics at Northwestern University, Chicago, said in a written statement.
“At busy clinics, sadly, the most efficient thing to do is just call in an antibiotic prescription. We need to dig into the data more, but we believe there is a lot of antibiotic prescribing for colds, the flu, and non-specific symptoms such as just not feeling well,” he said.
With all the concern in recent years about overuse, it’s hard to imagine that prescribers are still being free and easy with antibiotics, and Dr. Linder’s study will certainly have its skeptics.
Sloppy record keeping could be one explanation for the findings. A patient could really have needed an antibiotic, but it just wasn’t captured in coding. There are also valid reasons for prescribing antibiotics over the phone, such as acne and recurrent UTIs.
Dr. Linder, however, thinks it’s more than that. He explained his study, its implications, and the next steps in an interview at ID Week, an annual scientific meeting on infectious diseases.
The 2,413 prescribers in the study included physicians, surgeons, residents, fellows, nurse practitioners, and physician assistants in general and specialty practices. Patients were a mean of 43 years old: 60% were women and 75% were white. The most common antibiotic classes were penicillins, macrolides, and cephalosporins. Prescriptions were written from November 2015 through October 2017.
The work was funded by the Agency for Healthcare Research and Quality. Dr. Linder did not have any disclosures.
SOURCE: Linder JA et al. ID Week 2018 abstract 1632.
based on a review of more than half a million outpatient prescriptions to more than a quarter million patients at 514 clinics around Chicago.
The researchers looked to see if prescriptions had an ICD-10 code that indicated an antibiotic; they were liberal in their approach, considering over 21,000 codes to at least possibly signal the need for an antibiotic.
Almost half the time, there was nothing in the codes related to bacterial infection: 29% of scripts were written in connection with codes for high blood pressure, annual visits, and other noninfectious disorders; 17% of prescriptions were written with no diagnosis code at all.
The study is likely the largest to date to look at outpatient antibiotic prescribing patterns in the United States, and the findings are worrisome. “Nearly half the time, clinicians have either a bad reason for prescribing antibiotics, or don’t provide a reason at all. When you consider about 80% of antibiotics are prescribed on an outpatient basis, that’s a concern,” lead investigator Jeffrey A. Linder, MD, MPH, chief of the division of general internal medicine and geriatrics at Northwestern University, Chicago, said in a written statement.
“At busy clinics, sadly, the most efficient thing to do is just call in an antibiotic prescription. We need to dig into the data more, but we believe there is a lot of antibiotic prescribing for colds, the flu, and non-specific symptoms such as just not feeling well,” he said.
With all the concern in recent years about overuse, it’s hard to imagine that prescribers are still being free and easy with antibiotics, and Dr. Linder’s study will certainly have its skeptics.
Sloppy record keeping could be one explanation for the findings. A patient could really have needed an antibiotic, but it just wasn’t captured in coding. There are also valid reasons for prescribing antibiotics over the phone, such as acne and recurrent UTIs.
Dr. Linder, however, thinks it’s more than that. He explained his study, its implications, and the next steps in an interview at ID Week, an annual scientific meeting on infectious diseases.
The 2,413 prescribers in the study included physicians, surgeons, residents, fellows, nurse practitioners, and physician assistants in general and specialty practices. Patients were a mean of 43 years old: 60% were women and 75% were white. The most common antibiotic classes were penicillins, macrolides, and cephalosporins. Prescriptions were written from November 2015 through October 2017.
The work was funded by the Agency for Healthcare Research and Quality. Dr. Linder did not have any disclosures.
SOURCE: Linder JA et al. ID Week 2018 abstract 1632.
REPORTING FROM ID WEEK 2018
In utero efavirenz, dolutegravir exposure linked to childhood neurologic problems
SAN FRANCISCO – , according to a review of 3,747 children in the Surveillance Monitoring for ART Toxicities (SMARTT) study, an ongoing effort to monitor children exposed to antiretrovirals in the womb.
Overall, 237 children developed a neurologic complication at a mean age of 2; 16 of them were exposed to efavirenz. The study team estimated that 9.6% of children exposed to efavirenz had a neurological complication, versus 6.2% born to women on ART regimens without efavirenz. There was also a nonsignificant trend toward dolutegravir exposure and later neurological abnormalities, which occurred in four of 94 children exposed to the drug. Results were adjusted for maternal smoking and other risk factors.
No other safety signals were detected with the 19 other antiretrovirals analyzed in the study, lead investigator Claudia S. Crowell, MD, assistant professor of pediatrics at the University of Washington, Seattle, said at the annual scientific meeting on infectious diseases.
Efavirenz isn’t used much in the United States because there are more effective options with fewer side effects, but current guidelines recommend that women who are doing well on the drug stay on it while pregnant. Meanwhile, dolutegravir exposure at the time of conception was recently linked to an increased risk of neural tube defects in infants. The drug is commonly used in the United States, and guidelines have been strengthened to highlight the need for contraception use by women taking dolutegravir.
Dr. Crowell said she was surprised by her study’s findings, in part because efavirenz is not a teratogen. The work highlights how important it is to look beyond birth defects and follow children exposed to antiretrovirals for later problems. “We still haven’t determined what the safest regimen is for use in pregnancy,” she said.
Dr. Crowell explained the problem, and what her work means for practice in an interview at the meeting.
SOURCE: Crowell C et al. ID Week 2018 abstract LB5.
SAN FRANCISCO – , according to a review of 3,747 children in the Surveillance Monitoring for ART Toxicities (SMARTT) study, an ongoing effort to monitor children exposed to antiretrovirals in the womb.
Overall, 237 children developed a neurologic complication at a mean age of 2; 16 of them were exposed to efavirenz. The study team estimated that 9.6% of children exposed to efavirenz had a neurological complication, versus 6.2% born to women on ART regimens without efavirenz. There was also a nonsignificant trend toward dolutegravir exposure and later neurological abnormalities, which occurred in four of 94 children exposed to the drug. Results were adjusted for maternal smoking and other risk factors.
No other safety signals were detected with the 19 other antiretrovirals analyzed in the study, lead investigator Claudia S. Crowell, MD, assistant professor of pediatrics at the University of Washington, Seattle, said at the annual scientific meeting on infectious diseases.
Efavirenz isn’t used much in the United States because there are more effective options with fewer side effects, but current guidelines recommend that women who are doing well on the drug stay on it while pregnant. Meanwhile, dolutegravir exposure at the time of conception was recently linked to an increased risk of neural tube defects in infants. The drug is commonly used in the United States, and guidelines have been strengthened to highlight the need for contraception use by women taking dolutegravir.
Dr. Crowell said she was surprised by her study’s findings, in part because efavirenz is not a teratogen. The work highlights how important it is to look beyond birth defects and follow children exposed to antiretrovirals for later problems. “We still haven’t determined what the safest regimen is for use in pregnancy,” she said.
Dr. Crowell explained the problem, and what her work means for practice in an interview at the meeting.
SOURCE: Crowell C et al. ID Week 2018 abstract LB5.
SAN FRANCISCO – , according to a review of 3,747 children in the Surveillance Monitoring for ART Toxicities (SMARTT) study, an ongoing effort to monitor children exposed to antiretrovirals in the womb.
Overall, 237 children developed a neurologic complication at a mean age of 2; 16 of them were exposed to efavirenz. The study team estimated that 9.6% of children exposed to efavirenz had a neurological complication, versus 6.2% born to women on ART regimens without efavirenz. There was also a nonsignificant trend toward dolutegravir exposure and later neurological abnormalities, which occurred in four of 94 children exposed to the drug. Results were adjusted for maternal smoking and other risk factors.
No other safety signals were detected with the 19 other antiretrovirals analyzed in the study, lead investigator Claudia S. Crowell, MD, assistant professor of pediatrics at the University of Washington, Seattle, said at the annual scientific meeting on infectious diseases.
Efavirenz isn’t used much in the United States because there are more effective options with fewer side effects, but current guidelines recommend that women who are doing well on the drug stay on it while pregnant. Meanwhile, dolutegravir exposure at the time of conception was recently linked to an increased risk of neural tube defects in infants. The drug is commonly used in the United States, and guidelines have been strengthened to highlight the need for contraception use by women taking dolutegravir.
Dr. Crowell said she was surprised by her study’s findings, in part because efavirenz is not a teratogen. The work highlights how important it is to look beyond birth defects and follow children exposed to antiretrovirals for later problems. “We still haven’t determined what the safest regimen is for use in pregnancy,” she said.
Dr. Crowell explained the problem, and what her work means for practice in an interview at the meeting.
SOURCE: Crowell C et al. ID Week 2018 abstract LB5.
REPORTING FROM ID WEEK 2018
It’s time for universal CMV screening at birth
SAN FRANCISCO –
The reason is because most of the time the diagnosis of congenital cytomegalovirus is missed. Only about 10% of infants infected with the virus present with enlarged livers and other classic signs. Too often, the infection isn’t caught until later, when hearing loss and other neurologic sequelae reveal themselves, according to Fatima Kakkar, MD, a pediatric infectious disease specialist and researcher at the University of Montreal.
There are effective treatments – intravenous ganciclovir for 6 weeks or oral valganciclovir (Valcyte) for 6 months – that control the infection and reverse its effects.
People have tried to address the situation by screening children with hearing loss, in utero HIV exposure, or cytomegalovirus symptoms, but in a study Dr. Kakkar presented at IDWeek, an annual scientific meeting on infectious diseases, such targeted efforts still missed a lot of children.
Many think the answer is universal screening, and the Centers for Disease Control and Prevention are considering it. In a video interview at the meeting, Dr. Kakkar explained the issues, her study, and why universal screening is gaining support.
SOURCE: Kakkar F et al. IDWeek 2018, Abstract 115.
SAN FRANCISCO –
The reason is because most of the time the diagnosis of congenital cytomegalovirus is missed. Only about 10% of infants infected with the virus present with enlarged livers and other classic signs. Too often, the infection isn’t caught until later, when hearing loss and other neurologic sequelae reveal themselves, according to Fatima Kakkar, MD, a pediatric infectious disease specialist and researcher at the University of Montreal.
There are effective treatments – intravenous ganciclovir for 6 weeks or oral valganciclovir (Valcyte) for 6 months – that control the infection and reverse its effects.
People have tried to address the situation by screening children with hearing loss, in utero HIV exposure, or cytomegalovirus symptoms, but in a study Dr. Kakkar presented at IDWeek, an annual scientific meeting on infectious diseases, such targeted efforts still missed a lot of children.
Many think the answer is universal screening, and the Centers for Disease Control and Prevention are considering it. In a video interview at the meeting, Dr. Kakkar explained the issues, her study, and why universal screening is gaining support.
SOURCE: Kakkar F et al. IDWeek 2018, Abstract 115.
SAN FRANCISCO –
The reason is because most of the time the diagnosis of congenital cytomegalovirus is missed. Only about 10% of infants infected with the virus present with enlarged livers and other classic signs. Too often, the infection isn’t caught until later, when hearing loss and other neurologic sequelae reveal themselves, according to Fatima Kakkar, MD, a pediatric infectious disease specialist and researcher at the University of Montreal.
There are effective treatments – intravenous ganciclovir for 6 weeks or oral valganciclovir (Valcyte) for 6 months – that control the infection and reverse its effects.
People have tried to address the situation by screening children with hearing loss, in utero HIV exposure, or cytomegalovirus symptoms, but in a study Dr. Kakkar presented at IDWeek, an annual scientific meeting on infectious diseases, such targeted efforts still missed a lot of children.
Many think the answer is universal screening, and the Centers for Disease Control and Prevention are considering it. In a video interview at the meeting, Dr. Kakkar explained the issues, her study, and why universal screening is gaining support.
SOURCE: Kakkar F et al. IDWeek 2018, Abstract 115.
REPORTING FROM IDWEEK 2018
Opiate use tied to hepatitis C risk in youth
SAN FRANCISCO – A new study indicates young adults with opioid use disorder are seldom screened for hepatitis C virus infections; yet 11% of the subjects with opioid use disorder who were tested had been exposed to hepatitis C, and 6.8% had evidence of chronic hepatitis C infection.
Overall, 2.5% (6,812 subjects) of all subjects received hepatitis C testing and 122 (1.8%) tested positive. Based on health records, 23,345 had an ICD-9 code for any illicit drug use and 8.9% of those (2,090) were tested for HCV infection. Of the 933 subjects with an ICD-9 code for opioid use disorder, 35% were tested for HCV.
The results suggest that a group at significant risk of hepatitis C – those with opioid use disorder – is being overlooked in public health efforts to control the disease.
Clinicians may presume, “Oh, you just take opioids orally, you don’t inject drugs,” but oral opiate users can progress to intravenous drug use, Donna Futterman, MD, director of clinical pediatrics, Montefiore Medical Center, and professor of clinical pediatrics at Albert Einstein College of Medicine, both in New York, said during the press conference at the annual scientific meeting on infectious diseases.
Guidelines call for testing for hepatitis C only in individuals with known injected drug use, among other risk factors, but the research suggests that this significantly underestimates the population of teenagers and young adults who are at risk. Many who take opiates go on to use injectable drugs.
Another surprise finding in the study was that only 10.6% of those tested for hepatitis C had also been screened for human immunodeficiency virus (HIV).
The reasons for the low frequency of screening are likely complex, including lack of time, discomfort between the physician and patient, and concerns over privacy and stigma, according to Dr. Epstein, who emphasized the importance of communication to overcome such barriers.
“As a pediatrician, I try to be as open as possible with patients and let them know that anything they tell me is confidential. I start out discussing less private issues, things that are easier to talk about,” Dr. Epstein said.
But the results of the study also suggest that preconceived notions may be holding clinicians back from testing. “How can you test for hepatitis C and not think HIV?” Dr. Futterman said. “What is that differentiator in providers’ heads that makes them focus on one thing and not the other?”
SAN FRANCISCO – A new study indicates young adults with opioid use disorder are seldom screened for hepatitis C virus infections; yet 11% of the subjects with opioid use disorder who were tested had been exposed to hepatitis C, and 6.8% had evidence of chronic hepatitis C infection.
Overall, 2.5% (6,812 subjects) of all subjects received hepatitis C testing and 122 (1.8%) tested positive. Based on health records, 23,345 had an ICD-9 code for any illicit drug use and 8.9% of those (2,090) were tested for HCV infection. Of the 933 subjects with an ICD-9 code for opioid use disorder, 35% were tested for HCV.
The results suggest that a group at significant risk of hepatitis C – those with opioid use disorder – is being overlooked in public health efforts to control the disease.
Clinicians may presume, “Oh, you just take opioids orally, you don’t inject drugs,” but oral opiate users can progress to intravenous drug use, Donna Futterman, MD, director of clinical pediatrics, Montefiore Medical Center, and professor of clinical pediatrics at Albert Einstein College of Medicine, both in New York, said during the press conference at the annual scientific meeting on infectious diseases.
Guidelines call for testing for hepatitis C only in individuals with known injected drug use, among other risk factors, but the research suggests that this significantly underestimates the population of teenagers and young adults who are at risk. Many who take opiates go on to use injectable drugs.
Another surprise finding in the study was that only 10.6% of those tested for hepatitis C had also been screened for human immunodeficiency virus (HIV).
The reasons for the low frequency of screening are likely complex, including lack of time, discomfort between the physician and patient, and concerns over privacy and stigma, according to Dr. Epstein, who emphasized the importance of communication to overcome such barriers.
“As a pediatrician, I try to be as open as possible with patients and let them know that anything they tell me is confidential. I start out discussing less private issues, things that are easier to talk about,” Dr. Epstein said.
But the results of the study also suggest that preconceived notions may be holding clinicians back from testing. “How can you test for hepatitis C and not think HIV?” Dr. Futterman said. “What is that differentiator in providers’ heads that makes them focus on one thing and not the other?”
SAN FRANCISCO – A new study indicates young adults with opioid use disorder are seldom screened for hepatitis C virus infections; yet 11% of the subjects with opioid use disorder who were tested had been exposed to hepatitis C, and 6.8% had evidence of chronic hepatitis C infection.
Overall, 2.5% (6,812 subjects) of all subjects received hepatitis C testing and 122 (1.8%) tested positive. Based on health records, 23,345 had an ICD-9 code for any illicit drug use and 8.9% of those (2,090) were tested for HCV infection. Of the 933 subjects with an ICD-9 code for opioid use disorder, 35% were tested for HCV.
The results suggest that a group at significant risk of hepatitis C – those with opioid use disorder – is being overlooked in public health efforts to control the disease.
Clinicians may presume, “Oh, you just take opioids orally, you don’t inject drugs,” but oral opiate users can progress to intravenous drug use, Donna Futterman, MD, director of clinical pediatrics, Montefiore Medical Center, and professor of clinical pediatrics at Albert Einstein College of Medicine, both in New York, said during the press conference at the annual scientific meeting on infectious diseases.
Guidelines call for testing for hepatitis C only in individuals with known injected drug use, among other risk factors, but the research suggests that this significantly underestimates the population of teenagers and young adults who are at risk. Many who take opiates go on to use injectable drugs.
Another surprise finding in the study was that only 10.6% of those tested for hepatitis C had also been screened for human immunodeficiency virus (HIV).
The reasons for the low frequency of screening are likely complex, including lack of time, discomfort between the physician and patient, and concerns over privacy and stigma, according to Dr. Epstein, who emphasized the importance of communication to overcome such barriers.
“As a pediatrician, I try to be as open as possible with patients and let them know that anything they tell me is confidential. I start out discussing less private issues, things that are easier to talk about,” Dr. Epstein said.
But the results of the study also suggest that preconceived notions may be holding clinicians back from testing. “How can you test for hepatitis C and not think HIV?” Dr. Futterman said. “What is that differentiator in providers’ heads that makes them focus on one thing and not the other?”
REPORTING FROM ID WEEK 2018
Key clinical point: By focusing solely on injectable drug users, clinicians may miss many others who are at risk for hepatitis C infection.
Major finding: Among those with opiate use disorder, 11% tested positive for hepatitis C.
Study details: Survey of 269,124 teenagers and young adults visiting U.S. Federally Qualified Health Centers.
Disclosures: Dr. Epstein and Dr. Futterman have reported no conflicts of interest.
Encourage influenza vaccination in pregnant women
They are at greater risk for more severe illness, and influenza can lead to adverse outcomes in infants. The good news is that recent studies have shown that flu vaccines are safe and effective in pregnant women.
The bad news is that many women are hesitant to be vaccinated out of concerns over safety, in a trend that reflects broader societal worries over vaccination, said Dr. Chu, of the University of Washington, Seattle. In a video interview at an annual scientific meeting on infectious diseases, Dr. Chu advised steps to ensure that pregnant women are aware of the safety and efficacy of flu vaccines, and the benefits to the infant who acquires immunity through the mother. It’s also a good idea to have vaccine on hand to be able to offer it immediately during an office visit.
They are at greater risk for more severe illness, and influenza can lead to adverse outcomes in infants. The good news is that recent studies have shown that flu vaccines are safe and effective in pregnant women.
The bad news is that many women are hesitant to be vaccinated out of concerns over safety, in a trend that reflects broader societal worries over vaccination, said Dr. Chu, of the University of Washington, Seattle. In a video interview at an annual scientific meeting on infectious diseases, Dr. Chu advised steps to ensure that pregnant women are aware of the safety and efficacy of flu vaccines, and the benefits to the infant who acquires immunity through the mother. It’s also a good idea to have vaccine on hand to be able to offer it immediately during an office visit.
They are at greater risk for more severe illness, and influenza can lead to adverse outcomes in infants. The good news is that recent studies have shown that flu vaccines are safe and effective in pregnant women.
The bad news is that many women are hesitant to be vaccinated out of concerns over safety, in a trend that reflects broader societal worries over vaccination, said Dr. Chu, of the University of Washington, Seattle. In a video interview at an annual scientific meeting on infectious diseases, Dr. Chu advised steps to ensure that pregnant women are aware of the safety and efficacy of flu vaccines, and the benefits to the infant who acquires immunity through the mother. It’s also a good idea to have vaccine on hand to be able to offer it immediately during an office visit.
REPORTING FROM ID WEEK 2018
Flu outbreaks may be more intense in small cities
Influenza outbreaks in the United States tend to be concentrated and intense in small cities and more evenly spread throughout the season in large cities, results of a recent study show.
Swings in humidity further intensified the influenza spikes in small cities, but didn’t seem to have as much of an effect in large cities, the results suggest.
These findings help explain differences in influenza transmission patterns between cities that have similar climates and virus epidemiology, according to researcher Benjamin D. Dalziel, PhD, of the departments of integrative biology and mathematics at Oregon State University in Corvallis.
“City size and structure can play a role in determining how other factors such as climate affect and influence transmission,” Dr. Dalziel said in a press conference.
“Our results show how metropolises play a disproportionately important role in this process, as epidemic foci, and as potential sentinel hubs, where epidemiological observatories could integrate local strain dynamics to predict larger-scale patterns. As the growth and form of cities affect their function as climate-driven incubators of infectious disease, it may be possible to design smarter cities that better control epidemics in the face of accelerating global change,” the researchers wrote in their study.
Dr. Dalziel and his coauthors analyzed the weekly incidence of influenza-like illness across 603 U.S. ZIP codes using data obtained from medical claims from 2002 to 2008. They used epidemic intensity as a summary statistic to compare cities. By this variable, low epidemic intensity indicated a diffuse spread evenly across weeks of the flu season, whereas high epidemic intensity indicated intensively focused outbreaks on particular weeks.
In small cities, epidemics were more intensely focused on shorter periods at the peak of flu season, they found. In large cities, incidence was more diffuse, according to results published in Science.
Patterns of where people live and work in a city may account for the more diffuse and prolonged outbreaks seen in large cities, the authors wrote. Large cities have organized population movement patterns and crowding. In more highly established work locations, for example, the population density is pronounced during the day.
“We found the structure makes a difference for how the flu spreads at different times of year,” Dr. Dalziel said of the study, which used U.S. Census data to evaluate spatial population distributions. “In large cities with more highly organized patterns, conditions play a relatively smaller role in flu transmission.”
Humidity’s lower impact on outbreaks in large cities might also be explained by population effects: “If an infected person is sitting beside you, it matters less what the specific humidity is,” Dr. Dalziel said, adding that the proximity helps the virus find hosts even when climatic conditions are not at their most favorable.
The study findings may have implications for health care resources in small cities, which could be strained by intense outbreaks, said coinvestigator Cecile Viboud, PhD, of the Division of International Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, Md.
Intense outbreaks could overload the health care system, making it challenging to respond, especially around the peak of the epidemic. Pressure on the health care system may be less intense in cities such as Miami or New York, where flu epidemics are more diffuse and spread out during the year, she said.
Variations in vaccination coverage were not associated with variations in epidemic intensity at the state level. However, the data period that was analyzed ended in 2008, a time when flu vaccination rates were much lower than they are today, according to Dr. Viboud.
“It would be important to revisit the effect of city structure and humidity on flu transmission in a high vaccination regime in more recent years, especially if there is a lot of interest in developing broadly cross-protective flu vaccines, which might become available in the market in the future,” she said.
The researchers declared no competing interests related to their research, which was supported by a grant from the Bill & Melinda Gates Foundation, the RAPIDD program of the Science and Technology Directorate Department of Homeland Security, and the Fogarty International Center, National Institutes of Health.
SOURCE: Dalziel BD et al. Science. 2018 Oct 5;362(6410):75-9.
Public health policy makers may need to switch up their thinking about infection control during influenza outbreaks. Instead of targeting the population at large, it may make sense to focus on specific small towns or metropolitan areas for control.
Summary statistics, such as epidemic intensity, help to identify which places require more surge capacity to deal with peak health care demand. They also help to guide locations for active influenza surveillance where long transmission chains of influenza occur, and where new genetic variants of the influenza virus can be detected.
The findings of this study could foster the development of more accurate short-term, small-scale forecasts of the expected health care demand in a season. Most important, they could guide long-term projections that reveal how the shifting demography, growth of cities, and the changing climate alter infection dynamics and required control efforts.
Prof. Jacco Wallinga is with the Center for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands, and the Department of Biomedical Data Sciences, Leiden (the Netherlands) University Medical Center. These comments appeared in his editorial in Science (2018 Oct 5;362[6410]:29-30).
Public health policy makers may need to switch up their thinking about infection control during influenza outbreaks. Instead of targeting the population at large, it may make sense to focus on specific small towns or metropolitan areas for control.
Summary statistics, such as epidemic intensity, help to identify which places require more surge capacity to deal with peak health care demand. They also help to guide locations for active influenza surveillance where long transmission chains of influenza occur, and where new genetic variants of the influenza virus can be detected.
The findings of this study could foster the development of more accurate short-term, small-scale forecasts of the expected health care demand in a season. Most important, they could guide long-term projections that reveal how the shifting demography, growth of cities, and the changing climate alter infection dynamics and required control efforts.
Prof. Jacco Wallinga is with the Center for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands, and the Department of Biomedical Data Sciences, Leiden (the Netherlands) University Medical Center. These comments appeared in his editorial in Science (2018 Oct 5;362[6410]:29-30).
Public health policy makers may need to switch up their thinking about infection control during influenza outbreaks. Instead of targeting the population at large, it may make sense to focus on specific small towns or metropolitan areas for control.
Summary statistics, such as epidemic intensity, help to identify which places require more surge capacity to deal with peak health care demand. They also help to guide locations for active influenza surveillance where long transmission chains of influenza occur, and where new genetic variants of the influenza virus can be detected.
The findings of this study could foster the development of more accurate short-term, small-scale forecasts of the expected health care demand in a season. Most important, they could guide long-term projections that reveal how the shifting demography, growth of cities, and the changing climate alter infection dynamics and required control efforts.
Prof. Jacco Wallinga is with the Center for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands, and the Department of Biomedical Data Sciences, Leiden (the Netherlands) University Medical Center. These comments appeared in his editorial in Science (2018 Oct 5;362[6410]:29-30).
Influenza outbreaks in the United States tend to be concentrated and intense in small cities and more evenly spread throughout the season in large cities, results of a recent study show.
Swings in humidity further intensified the influenza spikes in small cities, but didn’t seem to have as much of an effect in large cities, the results suggest.
These findings help explain differences in influenza transmission patterns between cities that have similar climates and virus epidemiology, according to researcher Benjamin D. Dalziel, PhD, of the departments of integrative biology and mathematics at Oregon State University in Corvallis.
“City size and structure can play a role in determining how other factors such as climate affect and influence transmission,” Dr. Dalziel said in a press conference.
“Our results show how metropolises play a disproportionately important role in this process, as epidemic foci, and as potential sentinel hubs, where epidemiological observatories could integrate local strain dynamics to predict larger-scale patterns. As the growth and form of cities affect their function as climate-driven incubators of infectious disease, it may be possible to design smarter cities that better control epidemics in the face of accelerating global change,” the researchers wrote in their study.
Dr. Dalziel and his coauthors analyzed the weekly incidence of influenza-like illness across 603 U.S. ZIP codes using data obtained from medical claims from 2002 to 2008. They used epidemic intensity as a summary statistic to compare cities. By this variable, low epidemic intensity indicated a diffuse spread evenly across weeks of the flu season, whereas high epidemic intensity indicated intensively focused outbreaks on particular weeks.
In small cities, epidemics were more intensely focused on shorter periods at the peak of flu season, they found. In large cities, incidence was more diffuse, according to results published in Science.
Patterns of where people live and work in a city may account for the more diffuse and prolonged outbreaks seen in large cities, the authors wrote. Large cities have organized population movement patterns and crowding. In more highly established work locations, for example, the population density is pronounced during the day.
“We found the structure makes a difference for how the flu spreads at different times of year,” Dr. Dalziel said of the study, which used U.S. Census data to evaluate spatial population distributions. “In large cities with more highly organized patterns, conditions play a relatively smaller role in flu transmission.”
Humidity’s lower impact on outbreaks in large cities might also be explained by population effects: “If an infected person is sitting beside you, it matters less what the specific humidity is,” Dr. Dalziel said, adding that the proximity helps the virus find hosts even when climatic conditions are not at their most favorable.
The study findings may have implications for health care resources in small cities, which could be strained by intense outbreaks, said coinvestigator Cecile Viboud, PhD, of the Division of International Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, Md.
Intense outbreaks could overload the health care system, making it challenging to respond, especially around the peak of the epidemic. Pressure on the health care system may be less intense in cities such as Miami or New York, where flu epidemics are more diffuse and spread out during the year, she said.
Variations in vaccination coverage were not associated with variations in epidemic intensity at the state level. However, the data period that was analyzed ended in 2008, a time when flu vaccination rates were much lower than they are today, according to Dr. Viboud.
“It would be important to revisit the effect of city structure and humidity on flu transmission in a high vaccination regime in more recent years, especially if there is a lot of interest in developing broadly cross-protective flu vaccines, which might become available in the market in the future,” she said.
The researchers declared no competing interests related to their research, which was supported by a grant from the Bill & Melinda Gates Foundation, the RAPIDD program of the Science and Technology Directorate Department of Homeland Security, and the Fogarty International Center, National Institutes of Health.
SOURCE: Dalziel BD et al. Science. 2018 Oct 5;362(6410):75-9.
Influenza outbreaks in the United States tend to be concentrated and intense in small cities and more evenly spread throughout the season in large cities, results of a recent study show.
Swings in humidity further intensified the influenza spikes in small cities, but didn’t seem to have as much of an effect in large cities, the results suggest.
These findings help explain differences in influenza transmission patterns between cities that have similar climates and virus epidemiology, according to researcher Benjamin D. Dalziel, PhD, of the departments of integrative biology and mathematics at Oregon State University in Corvallis.
“City size and structure can play a role in determining how other factors such as climate affect and influence transmission,” Dr. Dalziel said in a press conference.
“Our results show how metropolises play a disproportionately important role in this process, as epidemic foci, and as potential sentinel hubs, where epidemiological observatories could integrate local strain dynamics to predict larger-scale patterns. As the growth and form of cities affect their function as climate-driven incubators of infectious disease, it may be possible to design smarter cities that better control epidemics in the face of accelerating global change,” the researchers wrote in their study.
Dr. Dalziel and his coauthors analyzed the weekly incidence of influenza-like illness across 603 U.S. ZIP codes using data obtained from medical claims from 2002 to 2008. They used epidemic intensity as a summary statistic to compare cities. By this variable, low epidemic intensity indicated a diffuse spread evenly across weeks of the flu season, whereas high epidemic intensity indicated intensively focused outbreaks on particular weeks.
In small cities, epidemics were more intensely focused on shorter periods at the peak of flu season, they found. In large cities, incidence was more diffuse, according to results published in Science.
Patterns of where people live and work in a city may account for the more diffuse and prolonged outbreaks seen in large cities, the authors wrote. Large cities have organized population movement patterns and crowding. In more highly established work locations, for example, the population density is pronounced during the day.
“We found the structure makes a difference for how the flu spreads at different times of year,” Dr. Dalziel said of the study, which used U.S. Census data to evaluate spatial population distributions. “In large cities with more highly organized patterns, conditions play a relatively smaller role in flu transmission.”
Humidity’s lower impact on outbreaks in large cities might also be explained by population effects: “If an infected person is sitting beside you, it matters less what the specific humidity is,” Dr. Dalziel said, adding that the proximity helps the virus find hosts even when climatic conditions are not at their most favorable.
The study findings may have implications for health care resources in small cities, which could be strained by intense outbreaks, said coinvestigator Cecile Viboud, PhD, of the Division of International Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, Md.
Intense outbreaks could overload the health care system, making it challenging to respond, especially around the peak of the epidemic. Pressure on the health care system may be less intense in cities such as Miami or New York, where flu epidemics are more diffuse and spread out during the year, she said.
Variations in vaccination coverage were not associated with variations in epidemic intensity at the state level. However, the data period that was analyzed ended in 2008, a time when flu vaccination rates were much lower than they are today, according to Dr. Viboud.
“It would be important to revisit the effect of city structure and humidity on flu transmission in a high vaccination regime in more recent years, especially if there is a lot of interest in developing broadly cross-protective flu vaccines, which might become available in the market in the future,” she said.
The researchers declared no competing interests related to their research, which was supported by a grant from the Bill & Melinda Gates Foundation, the RAPIDD program of the Science and Technology Directorate Department of Homeland Security, and the Fogarty International Center, National Institutes of Health.
SOURCE: Dalziel BD et al. Science. 2018 Oct 5;362(6410):75-9.
FROM SCIENCE
Key clinical point: The intensity of influenza epidemics in U.S. cities varies according to population.
Major finding: Smaller cities had more intense outbreaks concentrated around the peak of flu season, while larger cities had cases spread throughout the season.
Study details: Analysis of weekly influenza-like illness incidence for 603 U.S. ZIP codes in medical claims data from 2002 to 2008.
Disclosures: The authors declared no competing interests. Funding came from the Bill & Melinda Gates Foundation, the Science and Technology Directorate Department of Homeland Security, and the Fogarty International Center, National Institutes of Health.
Source: Dalziel BD et al. Science. 2018 Oct 5;362(6410):75-9.
FDA approves omadacycline for pneumonia and skin infections
The, for treating community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in adults, the manufacturer, Paratek, announced in a press release.
The company expects that omadacycline will be available in the first quarter of 2019. Administered once-daily in either oral or IV formulations, the antibiotic was effective and well tolerated across multiple trials, which altogether included almost 2,000 patients, according to Paratek. As part of the approval, the company has agreed to conduct postmarketing studies, specifically, more studies in CABP and in pediatric populations. “To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nuzyra and other antibacterial drugs, Nuzyra should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria,” according to a statement in the indications section of the prescribing information.
Omadacycline is contraindicated for patients with a known hypersensitivity to the drug or any members of the tetracycline class of antibacterial drugs; hypersensitivity reactions have been observed, so use should be discontinued if one is suspected. Use of this drug during later stages of pregnancy can lead to irreversible discoloration of the infant’s teeth and inhibition of bone growth; it should also not be used during breastfeeding.
Because omadacycline is structurally similar to tetracycline class drugs, some adverse reactions to those drugs may be seen with this one, such as photosensitivity, pseudotumor cerebri, and antianabolic action. Adverse reactions known to have an association with omadacycline include nausea, vomiting, hypertension, insomnia, diarrhea, constipation, and increases of alanine aminotransferase, aspartate aminotransferase, and/or gamma-glutamyl transferase.
Drug interactions may occur with anticoagulants, so dosage of those drugs may need to be reduced while treating with omadacycline. Antacids also are believed to have a drug interaction – specifically, impairing absorption of omadacycline
The, for treating community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in adults, the manufacturer, Paratek, announced in a press release.
The company expects that omadacycline will be available in the first quarter of 2019. Administered once-daily in either oral or IV formulations, the antibiotic was effective and well tolerated across multiple trials, which altogether included almost 2,000 patients, according to Paratek. As part of the approval, the company has agreed to conduct postmarketing studies, specifically, more studies in CABP and in pediatric populations. “To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nuzyra and other antibacterial drugs, Nuzyra should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria,” according to a statement in the indications section of the prescribing information.
Omadacycline is contraindicated for patients with a known hypersensitivity to the drug or any members of the tetracycline class of antibacterial drugs; hypersensitivity reactions have been observed, so use should be discontinued if one is suspected. Use of this drug during later stages of pregnancy can lead to irreversible discoloration of the infant’s teeth and inhibition of bone growth; it should also not be used during breastfeeding.
Because omadacycline is structurally similar to tetracycline class drugs, some adverse reactions to those drugs may be seen with this one, such as photosensitivity, pseudotumor cerebri, and antianabolic action. Adverse reactions known to have an association with omadacycline include nausea, vomiting, hypertension, insomnia, diarrhea, constipation, and increases of alanine aminotransferase, aspartate aminotransferase, and/or gamma-glutamyl transferase.
Drug interactions may occur with anticoagulants, so dosage of those drugs may need to be reduced while treating with omadacycline. Antacids also are believed to have a drug interaction – specifically, impairing absorption of omadacycline
The, for treating community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in adults, the manufacturer, Paratek, announced in a press release.
The company expects that omadacycline will be available in the first quarter of 2019. Administered once-daily in either oral or IV formulations, the antibiotic was effective and well tolerated across multiple trials, which altogether included almost 2,000 patients, according to Paratek. As part of the approval, the company has agreed to conduct postmarketing studies, specifically, more studies in CABP and in pediatric populations. “To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nuzyra and other antibacterial drugs, Nuzyra should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria,” according to a statement in the indications section of the prescribing information.
Omadacycline is contraindicated for patients with a known hypersensitivity to the drug or any members of the tetracycline class of antibacterial drugs; hypersensitivity reactions have been observed, so use should be discontinued if one is suspected. Use of this drug during later stages of pregnancy can lead to irreversible discoloration of the infant’s teeth and inhibition of bone growth; it should also not be used during breastfeeding.
Because omadacycline is structurally similar to tetracycline class drugs, some adverse reactions to those drugs may be seen with this one, such as photosensitivity, pseudotumor cerebri, and antianabolic action. Adverse reactions known to have an association with omadacycline include nausea, vomiting, hypertension, insomnia, diarrhea, constipation, and increases of alanine aminotransferase, aspartate aminotransferase, and/or gamma-glutamyl transferase.
Drug interactions may occur with anticoagulants, so dosage of those drugs may need to be reduced while treating with omadacycline. Antacids also are believed to have a drug interaction – specifically, impairing absorption of omadacycline
FDA approves Arikayce for MAC lung diseases
that has been caused by members of the Mycobacterium avium complex and is refractory to other treatments.
In a randomized, controlled trial, patients with refractory M. avium complex infections were assigned to receive either Arikayce plus a multidrug antibacterial regimen or just the antibacterial regimen. By 6 months, sputum cultures for 29% of those treated with the combination had shown no mycobacterial growth for 3 consecutive months, whereas this was only true for the cultures for 9% of patients on the multidrug antibacterial regimen alone.
The Arikayce prescribing information includes a boxed warning regarding the increased risk of respiratory conditions, including hypersensitivity pneumonitis, bronchospasm, exacerbation of underlying lung disease, and hemoptysis, some of which have proven serious enough to lead to hospitalization. Other side effects include dysphonia, cough, musculoskeletal pain, nausea, and fatigue.
According to the press announcement from the FDA, this is the first approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs, which was set up by Congress “to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need.” It does so by allowing a more streamlined clinical development program that may involve smaller, shorter, or fewer clinical trials.
More information can be found in the full press announcement.
that has been caused by members of the Mycobacterium avium complex and is refractory to other treatments.
In a randomized, controlled trial, patients with refractory M. avium complex infections were assigned to receive either Arikayce plus a multidrug antibacterial regimen or just the antibacterial regimen. By 6 months, sputum cultures for 29% of those treated with the combination had shown no mycobacterial growth for 3 consecutive months, whereas this was only true for the cultures for 9% of patients on the multidrug antibacterial regimen alone.
The Arikayce prescribing information includes a boxed warning regarding the increased risk of respiratory conditions, including hypersensitivity pneumonitis, bronchospasm, exacerbation of underlying lung disease, and hemoptysis, some of which have proven serious enough to lead to hospitalization. Other side effects include dysphonia, cough, musculoskeletal pain, nausea, and fatigue.
According to the press announcement from the FDA, this is the first approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs, which was set up by Congress “to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need.” It does so by allowing a more streamlined clinical development program that may involve smaller, shorter, or fewer clinical trials.
More information can be found in the full press announcement.
that has been caused by members of the Mycobacterium avium complex and is refractory to other treatments.
In a randomized, controlled trial, patients with refractory M. avium complex infections were assigned to receive either Arikayce plus a multidrug antibacterial regimen or just the antibacterial regimen. By 6 months, sputum cultures for 29% of those treated with the combination had shown no mycobacterial growth for 3 consecutive months, whereas this was only true for the cultures for 9% of patients on the multidrug antibacterial regimen alone.
The Arikayce prescribing information includes a boxed warning regarding the increased risk of respiratory conditions, including hypersensitivity pneumonitis, bronchospasm, exacerbation of underlying lung disease, and hemoptysis, some of which have proven serious enough to lead to hospitalization. Other side effects include dysphonia, cough, musculoskeletal pain, nausea, and fatigue.
According to the press announcement from the FDA, this is the first approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs, which was set up by Congress “to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need.” It does so by allowing a more streamlined clinical development program that may involve smaller, shorter, or fewer clinical trials.
More information can be found in the full press announcement.